Association of Tumour Grade and Sex Steroid Receptor as a Prognostic Index in Breast Cancer

Breast Cancer Clinical Trial

Official title:

Association of Tumour Grade and Sex Steroid Receptor as a Prognostic Index in Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04707287
• Other study ID #: LUMHS/REC/-17
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: January 15, 2021

Study information

• Verified date: January 2021
• Source: Liaquat University of Medical & Health Sciences
• Contact: Fazila Hashmi, FCPS
• Phone: 00923332608258
• Email: fazilahashmi[@]ymail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Null hypothesis: Histological grade of tumour bears no relation with the status of sex hormone receptors.

Alternate hypothesis: Both the histological grade of tumour and expression of sex steroid receptors are directly related to each other The investigators aim to;

1. see the relationship of sex steroid receptors with the histological grade of breast cancer.

2. evaluate the efficacy of steroid receptors as a prognostic factor

Description:

Breast cancer accounts for the largest number of deaths amongst the female population worldwide. It is now considered as a systemic disease even if diagnosed at an initial stage, as the clinical behaviour cannot be accurately predicted. Due to this reason, it is subjected to new dimensions of research every day. The aggressiveness of the cancer is directly proportional to the histopathological grade at the time of diagnosis. This is true with reference to the clinical stage at the time of presentation, the probability to metastasize and potential to recur. The idea of steroids receptor expression by the tumour is not new, and to evaluate their status prior to the induction of hormone therapy is a must.

The sex steroids, which are produced intratumorally, include estrogen, progesterone, and androgens. They act on their specific receptors present on the cell surface, within the cytoplasm and at the nuclear membrane. It is a measurement of these receptors that decide the potential of an individual to respond to different types of hormones like estrogen receptor blockers and aromatase inhibitors. Do the histological grade of tumour bears some relation with the status of these receptors and can investigators predict and rely just on the cellular behaviour of tumour for the purpose of prognosis is still under investigation. This study is designed to see the relationship between the histopathological grade of the tumour with the expression of sex steroid receptors. It will also try to evaluate whether these receptors bear some prognostic value or not.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 382
• Est. completion date: January 15, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients diagnosed with breast cancer irrespective of age, gender and clinical stage

Exclusion Criteria:

• Any patient who lost to follow up

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• No Intervention
No intervention used. This is observational study

Locations

Country	Name	City	State
Pakistan	Fazila Hashmi	Jamshoro	Sindh
Pakistan	Liaquat University of Medical and Health Sciences	Jamshoro

Sponsors (1)

Lead Sponsor	Collaborator
Liaquat University of Medical & Health Sciences

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

Clendenen TV, Ge W, Koenig KL, Afanasyeva Y, Agnoli C, Brinton LA, Darvishian F, Dorgan JF, Eliassen AH, Falk RT, Hallmans G, Hankinson SE, Hoffman-Bolton J, Key TJ, Krogh V, Nichols HB, Sandler DP, Schoemaker MJ, Sluss PM, Sund M, Swerdlow AJ, Visvanathan K, Zeleniuch-Jacquotte A, Liu M. Breast cancer risk prediction in women aged 35-50 years: impact of including sex hormone concentrations in the Gail model. Breast Cancer Res. 2019 Mar 19;21(1):42. doi: 10.1186/s13058-019-1126-z. — View Citation

Folkerd E, Dowsett M. Sex hormones and breast cancer risk and prognosis. Breast. 2013 Aug;22 Suppl 2:S38-43. doi: 10.1016/j.breast.2013.07.007. Review. — View Citation

Gadducci A, Biglia N, Sismondi P, Genazzani AR. Breast cancer and sex steroids: critical review of epidemiological, experimental and clinical investigations on etiopathogenesis, chemoprevention and endocrine treatment of breast cancer. Gynecol Endocrinol. 2005 Jun;20(6):343-60. Review. — View Citation

Gambardella A, Esposito D, Accardo G, Taddeo M, Letizia A, Tagliafierro R, Esposito K, Pasquali D. Sexual function and sex hormones in breast cancer patients. Endocrine. 2018 Jun;60(3):510-515. doi: 10.1007/s12020-017-1470-7. Epub 2017 Nov 14. — View Citation

Stute P, Wildt L, Neulen J. The impact of micronized progesterone on breast cancer risk: a systematic review. Climacteric. 2018 Apr;21(2):111-122. doi: 10.1080/13697137.2017.1421925. Epub 2018 Jan 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histopathology of tumour	The incidence of grade and type of breast cancer at the time of study will be recorded and analysed	6 months
Primary	Steroid receptor status	The concentrations of estrogen and progesterone receptor will be calculated and analysed.	6 months
Secondary	Age	The age of patient will be calculated and compared to the primary outcomes.	6 months
Secondary	State of menstruation	The onset of premenopausal and postmenopausal status of patient will be recorded	6 months
Secondary	Stage of tumour	The status of clinical and pathological stage of the breast cancer at the time of study will be analysed.	6 months